Recall Z-0098-2024— Encore Medical, LP

Name: FDA recall Z-0098-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-22

Class II · Ongoing

Class II FDA medical device recall by Encore Medical, LP, initiated 2023-08-22. It names one FDA 510(k) clearance: K041066. Product: REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130. Reason: Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation..

Recalling firm: Encore Medical, LP
Classification: Class II
Status: Ongoing
Initiated: 2023-08-22
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K041066 — ENCORE REVERSE SHOULDER PROSTHESISEncore Medical L.P.·cleared 2005-03-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130

Reason for recall

Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.